Imagine that, as you're reading this, you're doing so from a low income country. (Indeed, perhaps you are!)
Now imagine that we are joined by a family with a very young daughter, who has been diagnosed with pneumonia. The situation is grave and the family are concerned because the last two courses of antibiotics have failed to work. The doctors are unable to explain why, as the medicines have been Quality Assured by the government.
Perhaps it's antimicrobial resistance? Perhaps the medicines have been stored incorrectly and have degraded? Perhaps they've expired and the vendor altered the label? Perhaps they're fake? Perhaps... well there are a host of possible reasons. For now let's focus on the real problem: a dying child, without access to basic, effective treatments, because of where she lives.
It is estimated that 10.5% of medicines in low- and middle- income countries are fake or substandard (1). This is unsurprising, and possibly an underestimate, given that nearly 75% of governments are not considered to have a “stable, well-functioning and integrated regulatory system” (2).
Let's return to our story. There's hope: the family are informed of a nearby clinic that can provide treatment. However, the clinic operates outside of the State-sponsored health system and, it is whispered, smuggles in its medicines from a neighbouring country. These medicines are real yet illegitimate: Quality Assured by one country, but not approved by this one. Who is right? What should the family do...?
This scenario highlights how concepts like "quality" can be subjective and how authenticity is not necessarily binary. It also provides a small snapshot into the kind of dilemmas that uncertainty can cause in global health - for patients, doctors and regulators alike.
I explore these ideas, and the notion of the "Genuine Fake", in this podcast with Assoc Prof Patricia Kingori - please have a listen (it's about 15 mins long) and leave a comment below. I'd love to hear your thoughts and your own stories.
References
1. A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products. Geneva: World Health Organization (2017).
2. Khadem Broojerdi A, Baran Sillo H, Ostad Ali Dehaghi R, et al. The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage. Frontiers in Medicine 2020;7(457) doi: 10.3389/fmed.2020.00457
{Available at: https://www.frontiersin.org/articles/10.3389/fmed.2020.00457/full }
{For information about the WHO's Global Benchmarking Assessment Tool, head to: https://www.who.int/medicines/regulation/benchmarking_tool/en/ }
Thanks for reading. I'm currently researching these issues at the Ethox Centre of the University of Oxford, with the kind support of the Wellcome Trust. If you'd like to stay in the loop, please get in touch or join the community on this site.
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